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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02745080




Registration number
NCT02745080
Ethics application status
Date submitted
1/04/2016
Date registered
20/04/2016

Titles & IDs
Public title
Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis
Scientific title
A Randomized, Double-blind, Active Control, Multicenter Study to Evaluate the Efficacy at Week 52 of Secukinumab Monotherapy Compared With Adalimumab Monotherapy in Patients With Active Psoriatic Arthritis
Secondary ID [1] 0 0
2015-004477-32
Secondary ID [2] 0 0
CAIN457F2366
Universal Trial Number (UTN)
Trial acronym
EXCEED 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Secukinumab
Treatment: Other - Adalimumab

Experimental: Secukinumab 300 mg s.c. - Secukinumab 300 mg administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 48.

Active comparator: Adalimumab 40 mg s.c. - Adalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50.


Treatment: Other: Secukinumab
Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio

Treatment: Other: Adalimumab
Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved an American College of Rheumatology 50% (ACR50) Response at Week 52
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) at Week 52
Timepoint [3] 0 0
Baseline, Week 52
Secondary outcome [4] 0 0
Percentage of Participants Who Achieved Resolution of Enthesitis at Week 52
Timepoint [4] 0 0
Week 52

Eligibility
Key inclusion criteria
Key

* Diagnosis of PsA classified by CASPAR
* Rheumatoid factor and anti-CCP antibodies negative
* Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of >= 2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis
* Inadequate control of symptoms with NSAIDs
* Inadequate control of symptoms with a conventional DMARD.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or nursing women
* Evidence of ongoing infectious or malignant process
* Previous exposure to any biologic drug for Psoriatic Arthritis or Psoriasis
* Subjects taking high potency opioid analgesics
* Ongoing use of prohibited psoriasis treatments/medications
* Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 investigational agents.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/12/2019
Sample size
Target
Accrual to date
Final
853
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [2] 0 0
Novartis Investigative Site - Maroochydore
Recruitment hospital [3] 0 0
Novartis Investigative Site - Hobart
Recruitment hospital [4] 0 0
Novartis Investigative Site - Malvern East
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment postcode(s) [4] 0 0
3145 - Malvern East
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Kentucky
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United States of America
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Missouri
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United States of America
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Nebraska
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United States of America
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New York
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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Vermont
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United States of America
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Washington
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United States of America
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Wisconsin
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Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Quebec
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Czechia
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Bruntal
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Czechia
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Praha 2
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Czechia
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Praha 5
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Czechia
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Uherske Hradiste
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Czechia
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Zlin
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Denmark
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Frederiksberg
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Estonia
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Tallinn
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Estonia
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Tartu
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Finland
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Hyvinkaa
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Finland
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Kuopio
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France
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Brive-la-Gaillarde
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France
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Cahors
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France
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Chambray les Tours
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France
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Le Mans
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France
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Orleans
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France
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Paris
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France
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Poitiers
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Germany
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Bad Doberan
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Erlangen
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Germany
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Hamburg
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Germany
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Herne
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Germany
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Leipzig
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Germany
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Magdeburg
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Germany
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Osnabruck
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Germany
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Schwerin
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Greece
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Athens
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Greece
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Thessaloniki
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Gyor
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Kistarcsa
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Maharashtra
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India
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Telangana
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India
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Haifa
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Israel
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Kfar Saba
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Petach Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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GE
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Italy
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MI
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Italy
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VR
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Italy
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Bologna
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Italy
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Pisa
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Italy
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Torino
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Korea, Republic of
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Seocho Gu
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Riga
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Valmiera
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LTU
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Klaipeda
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Siauliai
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Netherlands
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Enschede
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Netherlands
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Sneek
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Dopiewo
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Porto
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Kemerovo
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Moscow
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Russian Federation
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Nizhny Novgorod
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Petrozavodsk
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Russian Federation
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Rostov on Don
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Smolensk
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Russian Federation
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Yaroslavl
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Slovakia
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Partizanske
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Slovakia
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Topolcany
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Spain
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Andalucia
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Spain
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Barcelona
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Spain
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Cantabria
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Catalunya
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Comunidad Valenciana
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Extremadura
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Galicia
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Pais Vasco
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Spain
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Santa Cruz De Tenerife
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Vizcaya
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Spain
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Madrid
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Sevilla
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Spain
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Valencia
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United Kingdom
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Devon
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Staffordshire
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United Kingdom
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Edinburgh
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United Kingdom
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Glasgow
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United Kingdom
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Hull
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Plymouth
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United Kingdom
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Solihull
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Wigan
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02745080